One of the most widely used methods of medical therapy is the intravenous (IV) infusion of liquid medicaments and/or nutrients into the bloodstream of a patient. A familiar apparatus that is used in many IV infusion applications is an IV container, such as an IV bag or bottle, which contains the liquid to be infused into the patient.
When the IV container is a bag, a rigid, hollow, sharpened IV spike is pushed into the bag to establish a pathway for fluid communication through which the liquid can flow out of the bag. The spike is usually inserted into the bag through a sealed membrane, commonly referred to as a port. In turn, the spike is connected to or formed integrally with an inlet port of a small, elongated, transparent hollow container familiarly referred to as a "drip chamber", with the fluid pathway of the spike in fluid communication with the inlet port of the drip chamber. Alternatively, the spike can be connected directly to an IV line to establish a pathway for fluid communication from the IV bag to the IV line. In either case, it is to be appreciated that once the spike has punctured the bag, fluid flow through the spike cannot be stopped in the event that the component to which the spike is connected must be removed from the IV set. This effectively limits modification of the IV set architecture once the spike is in place.
In my U.S. Pat. No. 5,391,150 for an invention entitled "IV BAG WITH NEEDLELESS CONNECTOR", Ser. No. 08/123,632, filed Sep. 16, 1993 for an invention entitled "LIQUID MEDICAMENT BAG WITH NEEDLELESS CONNECTOR FITTING USING BOAT ASSEMBLY", and Ser. No. 08/098,499, filed Jul. 28, 1993 for an invention entitled "DRIP CHAMBER WITH LUER FITTING", I have disclosed various needleless IV set components/including IV bags, cell culture bags configured essentially as IV bags, and IV drip chambers, which incorporate reflex valves and luer fittings to permit the easy and virtually drip-free assembly and/or modification of IV sets according to user-determined architectures, without requiring the use of sharp connectors, colloquially known as "sharps". By avoiding the use of sharps, my needleless components can help reduce the liklihood of medical personnel spreading blood diseases by inadvertently puncturing themselves with the sharps, and can help prevent damage to certain containers, e.g., IV bags, by minimizing the use of sharps.
As recognized by the present invention, however, many IV bags will continue to be manufactured with ports that have puncturable membranes, and that consequently require the use of spikes to establish a pathway for fluid flow out of the bag. Accordingly, the present invention recognizes that it would be advantageous to provide a spike which is compatible with other needleless IV set components.
Accordingly, it is an object of the present invention to provide a spike which does not require the use of "sharps" in infusing or extract fluid from the bag. Another object of the present invention to provide a spike which is easy to use and cost-effective to manufacture. A further object of the present invention is to provide a valve apparatus in an IV spike for engaging a complementary fitting, without the need to use a sharp connector and without requiring that the bag to which the spike is connected be empty of fluid, e.g., cell culture fluid.